Phlebotomy is often addressed as a crucial process in the pre-analytical phase, in which a large part of laboratory errors take place, but to date there is not yet a consolidated methodological paradigm” Ialongo and Bernardini (2017).
Phlebotomy is often addressed as a crucial process in the pre-analytical phase, in which a large part of laboratory errors take place, but to date there is not yet a consolidated methodological paradigm. Seeking literature, we found 36 suitable investigations issued between 1996 and 2016 (April) dealing with the investigation of pre-analytical factors related to phlebotomy.
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We found that the largest part of studies had a cohort of healthy volunteers (22/36) or outpatients (11/36), with the former group showing a significantly smaller median sample size (N = 20, IQR: 17.5-30 and N = 88, IQR: 54.5-220.5 respectively, P < 0.001). Moreover, the largest part investigated one pre-analytical factor (26/36) and regarded more than one laboratory test (29/36), and authors preferably used paired Student’s t-test (17/36) or Wilcoxon’s test (11/36), but calibration (i.e. sample size calculation for a detectable effect) was addressed only in one manuscript. The Bland-Altman plot was often the preferred method used to estimate bias (12/36), as well as the Passing-Bablok regression for agreement (8/36). However, often papers did assess neither bias (12/36) nor agreement (24/36). Clinical significance of bias was preferably assessed comparing to a database value (16/36), and it resulted uncorrelated with the size of the effect produced by the factor (P = 0.142). However, the median effect size (ES) resulted significantly larger if the associated factor was clinically significant instead of non-significant (ES = 1.140, IQR: 0.815-1.700 and ES = 0.349, IQR: 0.228-0.531 respectively, P < 0.001). On these evidences, we discussed some recommendations for improving methodological consistency, delivering reliable results, as well as ensuring accessibility to practical evidences.
Ialongo, C. and Bernardini, S. (2017) Preanalytical investigations of phlebotomy: methodological aspects, pitfalls and recommendations. Biochemia Medica. 27(1), p.177-191.
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